Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR

Completed · Not applicable

Conditions studied: Mitral Regurgitation, Mitral Valve Regurgitation

In brief

The COAPT Continued Access Study (CAS) is an extension of the COAPT RCT under the same IDE (G120024). COAPT CAS was a single-arm, prospective, multicenter continued access registry that enrolled heart failure patients with secondary mitral regurgitation who remained symptomatic despite optimal guideline-directed medical therapy (GDMT). The objective of the COAPT CAS is to continue the evaluation of safety and effectiveness of the MitraClip NT System under more "real world" conditions in patients who meet the COAPT inclusion/exclusion criteria and who have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS).

Key facts

Study ID

NCT07227675

Run by

Abbott Medical Devices

People needed

162

Starts

2017-10-23

Expected to finish

2024-03-31

Last updated by the study team

2025-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have national Medicare coverage by CMS
• Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology
• Subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure
• Subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected BNP ≥300 pg/ml or corrected NT-proBNP ≥1500 pg/ml
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
• Surgery will not be offered as a treatment option and medical therapy is the intended therapy for the subject
• Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50%
• Left Ventricular End Systolic Dimension (LVESD) is ≤70 mm

You may not qualify if…

• Untreated clinically significant coronary artery disease requiring revascularization
• Coronary artery bypass grafting (CABG) within prior 30 days
• Percutaneous coronary intervention within prior 30 days
• Tricuspid valve disease requiring surgery
• Aortic valve disease requiring surgery
• Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
• Cerebrovascular accident within prior 30 days
• Severe symptomatic carotid stenosis (> 70% by ultrasound)
• Carotid surgery within prior 30 days
• Mitral valve orifice area < 4.0 cm2
• Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip

Where it is running

• Scripps Green Hospital — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• El Camino Hospital — Mountain View, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• University of Colorado Hospital — Denver, Colorado, United States
• Mount Sinai Medical Center — Miami, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• Piedmont Hospital Atlanta — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Barnes Jewish Hospital — St Louis, Missouri, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• NYU Langone Medical Center — New York, New York, United States
• Columbia University Medical Center / New York Presbyterian Hospital — New York, New York, United States
• St. Francis Hospital — Roslyn, New York, United States
• Atrium Health Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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